For Industry

GDUFA Legislation and Background

On July 9, 2012, the President signed into law the Food and Drug Administration Safety and Innovation Act (FDASIA). This new law includes the Generic Drug User Fee Amendments of 2012 (GDUFA) which is designed to speed access to safe and effective generic drugs to the public. GDUFA authorizes the Food and Drug Administration (FDA) to collect fees from drug companies that submit marketing applications for certain generic human drug applications, certain drug master files, and certain facilities.

The current legislative authority for GDUFA expires at the end of September 2017. At that time, new legislation will be required for FDA to continue to collect generic drug user fees for future fiscal years.

This page is a resource for keeping the public and stakeholders informed of current events related to the reauthorization of GDUFA.